FDA Panel backs Ocriplasmin

FDA advisors ruled on July 26 that Ocriplasmin helped enough people in clinical trials to warrant a favourable review. The injectable drug is a truncated form of the human serine protease plasmin which retains its enzymatic properties. It’s used for the treatment of symptomatic vitreomacular adhesion, which occurs when vitreous gel detaches at the back of the eye but adheres to the retina as it pulls away, distorting vision and causing small breaks to develop in the macula.

The panel decided in an 6-3 split decision, that there is no need for additional studies despite evidence of adverse effects including eye pain, swelling and impaired vision. Nevertheless, Michael Repka, Chairman of the panel said, that post-market studies on this topic „would be nice“, reported Bloomberg.

A regulatory review published a day before the panel’s decision has sent the drugmaker’s stock price rollercoasting. A warning on serious adverse events in the report sent down the quotation by 19% at NYSE Euronext in Brussels. The Belgian Biotech Company tried to pour oil on troubled waters. "We have evidence that these things are all transient. There is nothing that is really sustained. Of course, we will address this during the discussion," ThromboGenics CFO Chris Buyse told Reuters. On July 27, the first day after the panel’s favourable decision, stock quotes raised by 13% to 26.37 Euro.

ThromboGenics, based in Heverlee, has already sold rights to the drug outside the U.S. to Swiss drugmaker Novartis AG. Its Alcon unit paid $99m upfront and promised close to $400m more in milestones to gain the rights to commercialise the drug.

29.07.2015 Newly founded Mereo BioPharma has acquired three mid-stage clinical assets from Novartis. In turn, the Swiss pharma concern will hold a stake in the UK company. Other investors are also on board.

24.07.2015 Biotech companies across Europe continue to raise cash on the public markets, generating €3bn in total financing proceedings in the first half of 2015. Compared to 2014, this is almost twice as much.

23.07.2015 US money keeps flowing into Europe's biotechs. As the race for the peanut allergy market heats up, NASDAQ listed French biotech DBV has announced the successful closing of US$281m (€256m) share offering for its allergy products.

16.07.2015 Sanofi has announced plans to restructure its business in five standalone global business units starting in January 2016. The goal is to promote growth and help the company launch a catalogue of new drugs over the next five years.

15.07.2015 GlaxoSmithKline (GSK) has become the first drugmaker to join the Francis Crick Institute. It is a consortium made up of six scientific and academic institutes to conduct research and drug development in the UK. The new institute is set to become a world-leading centre of biomedical research and innovation.

10.07.2015 Karolinska Development has slashed the reported value of its portfolio by almost half by revising its valuation model for early stage companies and divesting its shares in pain med maker Pharmanest.

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